EPA Finalizes
Rule for Human Studies Research(Beyond Pesticides, January 31, 2006) The
Environmental Protection Agency (EPA) finalized the rules that allows
for human pesticide testing and the use of resulting data for pesticide
registration after receiving over 50,000 comments during a 90-day public
comment period see Photo
Stories. The final rule, which amends 40 CFR Part 26 Protections
for Subjects in Human Research, continues a major controversy over
human testing that erupted when the Bush Administration reversed a federal
government prohibition on this type of testing.

The
rule (70 FR 53838) will ban all third-party intentional dosing research
on pesticides involving children and pregnant women intended for submission
to EPA, and EPA will neither conduct nor support any intentional dosing
studies that involve pregnant women or children for all substances EPA
regulates. According to EPA officials, the new rules will also establish
stringent enforceable ethical safeguards to protect individuals who
volunteer to participate in third-party intentional dosing research.
Although EPA is assuring the highest levels of safeguards available,
what continues to be an ssue with this rule is pesticide “benefits”
do not justify the intentional dosing of human subjects even on a voluntary
basis. According to Beyond Pesticides, It is unethical to test toxic
chemicals on human subjects when there is not documented and fully determined
societal benefit. Most toxic pesticide uses can be replaced by less
toxic alternative practices and products.

In a news
release issued by EPA, Susan Hazen, acting assistant administrator
in EPA's Office of Prevention, Pesticides and Toxic Substances said,
"These final rules will protect pregnant women and children from
unethical human research involving pesticides and other environmental
substances." Hazen continued, "Pregnant women and children
should never be involved in these types of studies. Now adult volunteers
(non-pregnant) will have the highest level of ethical safeguards available
if they choose to participate in research studies."

Examples of human
research studies include measuring worker exposure levels. Exposing
subjects to low doses of a substance to measure how it is absorbed,
distributed, metabolized, and excreted. Lastly, although according to
EPA, they have not required or encouraged it, occasionally some third
parties have conducted and submitted to EPA reports of research involving
intentional exposure to human subjects to a substance to identify or
measure its toxic effects. The latter studies occur in a controlled
laboratory or clinical setting says EPA.

In the final rule,
Protections for Subjects in Human Research, EPA says it intends
to significantly strengthen and expand the protection for participants
in third party research by:

Prohibiting
new research involving intentional exposure of pregnant woman or children,
intended for submission to EPA under pesticide laws;

Extending the
ethical protections in the Federal Policy for the Protection of Human
Subjects of Research (the
“Common Rule”) to other human research involving intentional
exposure of non-pregnant adults, intended for submission to EPA under
pesticide laws;

Requiring submission
to EPA of protocols and related information to ensure any future studies
meet this highest ethical safegrounds; and

Establishing
an independent Human
Studies Review Board (HSRB) to obtain expert peer review of both
proposals for new research and completed third party intentional dosing,
research on which EPA may rely under the pesticide laws.

In addition, the
final rule also:

Categorically
prohibits any EPA-sponsored research involving intentional exposure
of pregnant women or children to any environmental substance; and

Adopts regulations
of the Department of Health and Human Services to provide additional
protections beyond those of the Common Rule to pregnant women and
children in EPA observational research where there is only minimal
risk and when research which does not involve intentional exposure
to any substance.

Although the EPA
rule has expanded the Common Rule, EPA has not proposed to adopt subpart
C of the Common Rule at this time, which provides additional protections
pertaining to biomedical and behavioral research involving prisoners
as subjects. EPA is waiting for recommendations (which is expected to
consist of significant changes) to come from an advisory committee out
of the Department of Health and Human Services (HHS). The agency decided
to defer the decision until the possible HHS revisions are settled since
EPA neither conducts nor supports research with prisoners, and has not
received any third party research with prisoners for many years.

In the new rule
adult volunteers (non-pregnant) who choose to participate in this research
will have the highest level of ethical safeguards available, according
to EPA.

EPA does not evaluate
pesticides for their societal benefits in light of alternative approaches,
practices and products. EPA does not by practice or rule, under the
“unreasonable adverse effects” standard of the federal pesticide
registration law (Federal Insecticide, Fungicide and Rodenticide
Act - FIFRA), generally evaluate the actual need for a pesticide
to determine whether the pest is adequately defined and, if so, whether
there is a less toxic approach to pest prevention or management. Therefore,
EPA is not equipped to meet the rule’s requirement that human
studies are approved “only if risks to subjects . . . are reasonable
in relation to anticipated benefits.” This is a threshold issue
when discussing the ethics of intentionally dosing human subjects with
pesticides.

Within this rule
EPA acknowledges it’s mission is to make the best possible regulatory
decisions to protect public health and the environment. The Agency does
not want to ignore potentially important information that might benefit
its assessments and decision-making. According to EPA, the sweeping
requirements of this final rule will lay the groundwork and provide
an important foundation for the Agency to build upon in future actions
that may be determined necessary to provide further protections to public
health.

Observational studies
that encourage pesticide use with incentives remain unaffected by the
rule. Studies such as the highly controversial, and at least temporarily
derailed Children’s Environmental Exposure Research Study (CHEERS),
would not be outlawed or restricted by the proposed rule.

For more information,
see Human Testing
Daily News Stories and contact Beyond pesticides. Use the Google
search engine on the Beyond Pesticide homepage to find a series of articles
on this subject.